cGMP consulting

Current Good Manufacturing Practices (cGMP’s) is a quality systems that regulates products (food, drugs, biologics, and devices).

cGMP are guidelines that have to be applied, as part of a quality control system, to guarantee batch consistency and compliance to product specification as stated in registration dossier.

Procelltech can offer consultancy for designing production units for Advanced Therapy medicinal products in compliance with cGMP.

Procelltech can offer consultancy for drafting and managing documents to prepare request dossier to regulatory authority cGMP authorization (e.g. Site Master File, Validation Master Plan).

Procelltech can also provide consultancy on the management of GMP documentation (e. g. standard operating procedures, working instructions, risk assessment and validation process protocols and reports).

Procelltech can also offer training courses on standard GxP (GLP, GMP) guidelines and can give consultancy on “customized” training classes that can be organized according to client requirements.